MAUDE Adverse Event Report: ENCORE MEDICAL L.P. SCREWDRIVER; SCREW DRIVER, HEX HEAD

Catalog Number	801-01-042
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Instrument failure - the hex head is worn out.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was reported as hex head is worn out.The possible time in service of the screwdriver is 7.6 years.This event occurred during surgery near the patient.The healthcare professional indicated this as a significant adverse event.There was another suitable device available, the incident did not cause a delay in surgery and the surgery was completed as intended.The instrument was not inspected prior to surgery.The hex head of the screw driver is worn out.The reported condition could possibly be a result of heavy use, misuse, wear and care must be taken to avoid compromising their performance, refer to the ifu.A review of the device history record (dhr) revealed, when released for use, the items met design and manufacturing requirements.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.There had been three previous complaints against the reported lot number.Summary of complaints: 5 functional, 52 dull/worn, 1 locking mechanism damaged, 10 threads damaged/galled, 1 bent, 6 broke/cracked/damaged, 2 wear/excessive wear, 1 end of life and 13 blank.The root cause of this event is attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.There are no indications that this instrument has a design or material deficiency therefore no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.

• Brand Name: SCREWDRIVER
• Common Device Name: SCREW DRIVER, HEX HEAD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 10523285
• Report Number: 1644408-2020-00762
• Device Sequence Number: 16849621
• Product Code: HXX
• UDI-Device Identifier: 00888912127165
• UDI-Public: (01)00888912127165
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 801-01-042
• Device Lot Number: 98341L13
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other